In
two separate clinical trials of patients with advanced disease, both Afinitor
(everolimus), and Sutent (sunitinib) each halted cancer growth for a
significantly longer period of time than placebo.

Those
on Sutent had no cancer growth for roughly 11 months, compared with an average
of six months for those on placebo, according to Dr. Eric Raymond of Hopital
Beaujon in Clichy, France, and colleagues.

Those
on Afinitor also had about 11 months of progression-free survival, compared
with just less than five months for placebo patients, according to Dr. James
Yao of MD Anderson Cancer Center in Houston.

The
two studies were published in the Feb. 10 issue of the New England Journal of
Medicine.

Pancreatic neuroendocrine tumors have garnered attention in
recent months because Steve Jobs, the world-renowned CEO of technology giant
Apple, has had them. Last month, Jobs
announced another leave of absence from the company -- about two
years after taking leave to receive a liver transplant likely caused by disease
metastases there.

The
disease is typically treated with surgery, followed by therapy directed at the
liver if metastases develop there, as they often do.

Streptozocin
remains the only chemotherapy agent approved for treatment of the tumors,
though clinicians have debated its benefits.

Meanwhile,
researchers say the incidence of the disease is rising, as five-year survival
remains low, especially for those with metastatic disease, at 30 percent to 40
percent. Those numbers haven't changed much in the last 20 years, researchers
say, because no new treatments have been developed.

Earlier
studies of both Sutent and Afinitor had shown potential survival benefits in
these tumors, so the researchers set up bigger trials for both drugs in larger
numbers of patients with progressive, malignant disease.

Raymond
and colleagues enrolled 171 patients who were randomized to 37.5 mg/day of
Sutent or placebo.

They
halted the trial early based on data from 154 patients because of fewer side
effects and a greater magnitude of benefit with the drug -- the median
progression-free survival was double that of those on placebo.

That
translated to a 58 percent decreased risk of progression in the Sutent group.

There
was also improved overall survival with Sutent, seen with nine deaths in that
group compared with 21 in the placebo group.

The
findings suggest that neuroendocrine tumors “may be particularly sensitive” to
inhibition of the growth factors that the drugs target, they wrote.

The
most frequent side effects in the Sutent group were diarrhea, nausea, asthenia,
vomiting, and fatigue. The researchers also saw greater a proportion of
hypertension in patients on the drug.

For
the Afinitor study, Yao and colleagues enrolled 410 patients who were
randomized to 10 mg/day of the drug or placebo.

They
found that patients on the drug had significantly longer progression-free
survival compared with placebo patients, which translated to a 65 percent
reduced risk of progression.

After
a year and a half, 34 percent of those on Afinitor were progression-free,
compared with 9 percent of those on placebo, "indicating that a sizable
proportion of patients derived a prolonged benefit with Afinitor," the
researchers wrote.

Yet
they could not assess overall survival outcomes because 73 percent of placebo
patients eventually crossed over to Afinitor, "confounding the detection
of a treatment-related survival benefit."

Although
there were more side effects in the drug group, they were mostly minor, and
included rash, diarrhea, fatigue, and infections.

In
an accompanying editorial, Dr. Robert Jensen of the National Institute of
Diabetes and Digestive and Kidney Diseases in Bethesda, Md., and Dr. Gianfranco
Delle Fave of the University La Sapienza in Rome, wrote that the results
"hold promise" for patients with pancreatic neuroendocrine tumors
because "both drugs are effective at improving disease-free survival, even
in patients in whom other treatments have failed."

Yet
they noted that the question of whether the improvements in progression-free
survival with Afinitor will lead to improved overall survival, as seen with
Sutent.

They
also warned that the drugs stabilize the disease, rather than cure it, which
begs the question of whether patients will need to remain on them for years.

Jensen
and Delle Fave also mentioned that it isn't clear whether Sutent and Afinitor
can be combined, and whether such a combination would improve antitumor
activity.

The
answers to these questions, they wrote, "will be particularly important in
helping to determine the widespread usefulness of these new drugs in the
treatment of malignant pancreatic neuroendocrine tumors."

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